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The vaccine’s success with the simian AIDS virus has been nothing short of remarkable. Not only did the vaccine prevent the infection, it kept it under control for the monkeys that already had it, putting it in a kind of remission.

optimistic thank you for giving me hope for the futurethis could be the big one, the big big thingi tried to start a group called Vaccines for Aids in 1989 and I put ads in many gay newspapersbut i did not have the knowledge on how to create such a thing and i think that it was too early, look it took bill gates till last year

President Bill Clinton announced a 10-year goal for the development of an HIV/AIDS vaccine

Harriet L. Robinson1 and Kent J. Weinhold2

Emory Vaccine Center and Division of Microbiology and Immunology, Yerkes Primate Research Center and Emory

Nine years ago, in his 1997 Morgan State College commencement address, President Bill Clinton announced a 10-year goal for the development of an HIV/AIDS vaccine. A cornerstone of this plan was the establishment of a vaccine research center on the National Institutes of Health (NIH) campus in Bethesda, Maryland. We are now close to reaching 10 years and are unlikely to realize an effective HIV/AIDS vaccine by 2007. Nevertheless, the NIH Vaccine Research Center (VRC), which opened in 2001, has become a force in vaccine research and development and, in this issue of the Journal, publishes a pair of articles [1, 2] reporting the results of phase 1 human trials for its HIV/AIDS vaccines, which are now well into phase 2 studies. The vaccine strategy uses DNA to prime the immune response and a replication-defective recombinant adenovirus serotype 5 (rAd5) vector to boost responses.

All in all, the development of an HIV/AIDS vaccine has been slow, hard work. Major problems have been the lack of immune correlates for protection, the extensive genetic diversity of the virus, and the inability to elicit neutralizing antibodies for incident isolates [3, 4]. Because of the problem in raising neutralizing antibodies, vaccine efforts have turned to eliciting T cells that, at least in preclinical nonhuman primate models, can protect CD4+ T cells and control infections to the low levels found in successful drug treatment [5, 6]. The 2 articles for the DNA and rAd5 vaccines being developed by the VRC represent the first published reports of the elicitation of anti-HIV T cells in the vast majority of participants in a human trial.

Eighty-six volunteers rolled up their sleeves for the phase 1 testing of the HIV/AIDS candidate vaccines. The vaccine strategy is designed to recognize and hopefully protect against the diversity of isolates present in the worldwide AIDS pandemic. To achieve broad protection, the strategy uses multiple DNAs expressing copies of HIV-1 genes from the 3 dominant genetic subtypes of HIV-1 (clades A, B, and C) to prime immune responses followed by multiple adenovirus vectors, again expressing sequences from the 3 dominant subtypes, to boost responses. In the phase 1 trials reported in this issue, the DNA and rAd5 vaccines were tested separately for their safety and immunogenicity.

The DNA studies are a landmark for DNA-based vaccines in that they are the first to demonstrate a DNA vaccine successfully eliciting immune responses in essentially all vaccinated volunteers (table 1). Four DNA constructs constituted the DNA vaccine: 1 expressing a clade B Gag-Pol-Nef fusion protein, and 3 expressing individual clades A, B, and C Env glycoproteins [7, 8]. Three intramuscular injections of DNA were given with a needle-free bioject device at weeks 0, 4, and 8, with a dose escalation from 2 to 8 mg (the highest dose used to date) of total DNA. Both antibody and T cell responses were highest for the Env antigens in the vaccine (table 1). Both the elicited antibody and T cells showed multiclade activity. The 4- and 8-mg doses (but not the 2-mg dose) were, overall, similarly effective in eliciting immune responses. Table 1. Elicited immune responses.

The rAd5 HIV vaccine had both a higher percentage of responders and, overall, a higher magnitude of responses than did the DNA vaccine, especially for T cell responses (table 1). Four replication-defective rAd5 vectors expressed a clade B Gag-Pol fusion protein (Nef was not included because of problems with vector stability) and the clade A, B, and C Env glycoproteins. A single intramuscular immunization was given, with a dose escalation from 109 to 1011 particle units (PUs). Antibody and CD4+ T cells were elicited in essentially all vaccine recipients, and CD8+ T cell responses were elicited in 50%–70% of the volunteers (table 1). The highest rAd5 dose was accompanied by transient systemic adverse effects in some volunteers; however, it also elicited the best persistence of responses. Preexisting immunity to endemic adenovirus infections can limit the effectiveness of rAd5 vaccines. In this study, preexisting immunity to rAd5 was present in 32% of the volunteers and reduced the magnitude of the vaccine-elicited T cell response by slightly more than 3-fold.

Both the DNA and Ad5 candidate vaccines elicited higher responses against Env than against Gag. Natural HIV infections elicit higher T cell responses against Gag than against Env, and anti-Gag CD8+ T cell responses show a better correlation with protection than do anti-Env CD8+ T cell responses [9, 10]. The bias against the elicitation of anti-Gag T cells was not due to dose, because the vaccine mixtures were constituted to contain 50% Gag-expressing and 50% Env-expressing sequences. Rather, it appears to reflect a property of the Gag fusion protein, and 3 separate constructs for Gag, Pol, and Nef now replace the fusion protein in the "improved" DNA vaccine that the VRC is taking forward [11]. The expressed Env sequences are deleted for the proteolytic cleavage site that gives rise to the gp120 and gp41 forms of Env, as well as functional regions within gp41 [7]. These Env immunogens elicit good binding antibody but fail to elicit the hoped-for neutralizing antibody for incident isolates.

Recent studies being reported at meetings show excellent boosting of the DNA-primed response by the rAd5 component of the vaccine strategy [12]. Rollover of volunteers receiving 4 or 8 mg of DNA into a trial testing the rAd5 boost (1010 PUs) demonstrated >5-fold increases in T cell responses and >1000-fold increases in the levels of anti-Env binding antibody. These increases in immune responses occurred for boosts given 9 months to 2 years after the DNA prime.

On the basis of these findings, phase 2 studies have been undertaken in the Americas, South Africa, and East Africa to prepare for efficacy studies testing for multiclade protection. The immunogens are 4 mg of a 6-component DNA vaccine (clade B Gag, Pol, Nef, and Env plus clade A and C Env DNAs) and 1010 PUs of the 4-component rAd5 vaccine. Volunteers are being typed for preexisting immunity to adenovirus serotypes 5 and 35, to determine the extent to which preexisting immunity will affect immune responses to the vaccine in different regions of the world.

The rAd5-vectored vaccine that is most advanced in human trials is the one developed by Merck [13]. This vaccine uses 3 separate clade B Gag, Pol, and Nef vectors to both prime and boost the immune response in a 3-dose regimen [14]. A proof-of-concept trial for this vaccine, which does not have a component designed to elicit protective antibody, was initiated in December 2004 in 1500 adenovirus serotype 5–seronegative volunteers in the Americas, where clade B predominates, and then extended to include 1500 adenovirus serotype 5–seropositive volunteers. Merck has decided to discontinue a DNA prime for its rAd5-vectored vaccine.

The rAd5-vectored vaccines represent the third major vaccine concept to progress to extensive testing in human trials. The first was VaxGen's alum-adjuvanted gp120 protein, which elicited anti-gp120 binding antibody but failed to provide protective immunity [15]. The second, an Aventis Pasteur replication-defective canarypox vector (ALVAC) boosted with the VaxGen alum-adjuvanted B/E gp120 protein, is currently in efficacy trials in Thailand [16]. In phase 2 trials, this vaccine elicited antiviral T cells in <30% of the participants. In contrast to these earlier vaccines, the rAd5 vaccines successfully elicit T cells in the vast majority of volunteers. However, despite a highly promising initial trial in 3 macaques [17], these vectors have been found to provide relatively poor protection in macaques against both chimeras of simian and human immunodeficiency viruses (SHIVs) and simian immunodeficiency viruses (SIVs) [18, 19]. Other concepts that have shown higher protective potential in preclinical macaque models are presently in phase 1 human trials [20]. If the ALVAC prime and VaxGen gp120 boost were to work, or if the Merck proof-of-concept trial were to give favorable results, we could possibly identify an efficacious vaccine by 2008 or 2009—only 1 or 2 years past the 2007 goal. However, if these candidate vaccines are not protective, there are solid candidates waiting in the wings that give us a real chance to have an HIV/AIDS vaccine by 2017. Whether it will be the constructs of the NIH VRC or those of others that prove to be the most effective, the VRC will have played a dynamic role in spurring the development of a much-needed HIV/AIDS vaccine.

T-cell responses were remarkably stable over time and, unlike responses in most immunodeficiency virus infections, maintained good functional characteristics, as evidenced by coproduction of IFN-{gamma} and interleukin-2. Overall, high titers of binding and neutralizing antibody persisted throughout the postchallenge period. Encouragingly, long-term control was effective in macaques of diverse histocompatibility types.

Emory Vaccine Center and Yerkes National Primate Research Center, Emory University,1Emory Vaccine Center and Department of Medicine, Division of Infectious Diseases of Emory University School of Medicine, Atlanta, Georgia,4 Department of Surgery, Duke University Medical Center, Durham, North Carolina,2 Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland3

Received 21 September 2004/ Accepted 10 November 2004

In 2001, we reported 20 weeks of control of challenge with the virulent 89.6P chimera of simian and human immunodeficiency viruses (SHIV-89.6P) by a Gag-Pol-Env vaccine consisting of DNA priming and modified vaccinia virus Ankara boosting. Here we report that 22 out of 23 of these animals successfully controlled their viremia until their time of euthanasia at 200 weeks postchallenge. At euthanasia, all animals had low to undetectable viral loads and normal CD4 counts. During the long period of viral control, gamma interferon (IFN-{gamma})-producing antiviral T cells were present at unexpectedly low breadths and frequencies. Most animals recognized two CD8 and one CD4 epitope and had frequencies of IFN-{gamma}-responding T cells from 0.01 to 0.3% of total CD8 or CD4 T cells. T-cell responses were remarkably stable over time and, unlike responses in most immunodeficiency virus infections, maintained good functional characteristics, as evidenced by coproduction of IFN-{gamma} and interleukin-2. Overall, high titers of binding and neutralizing antibody persisted throughout the postchallenge period. Encouragingly, long-term control was effective in macaques of diverse histocompatibility types.

Emory University’s world- renowned Yerkes National Primate Research Center, the oldest and one of the larger scientific institutes dedicated to biomedical and behavioral research with non-human pri- mates, is embarking on a new stand-alone 92,000-square-foot building slated for completion in May 2004 that will concentrate on neuroscience research. More than 200 scientists conduct research at the center, supported by a staff of 250. Nearly 100 graduate and undergraduate students gain experience at the center. Also new at Emory is the $81.3 million Whitehead Biomedical Research Building just opened in 2002. It features eight floors and 325,000 square feet of office and state-of-the-art laboratory equipment and houses the departments of cell biology, human genetics, physiology, the Neurodegenerative Disease Center and the center for medical genomics. “We needed a living, breathing structure to attract and retain the best researchers in the world. You are in that building [Whitehead] today.” – Michael Johns, executive vice president for health affairs Last May, Emory opened the Biomedical Imaging & Technology Center. Soon to be open is Emory’s most recent gem, the Winship Cancer Institute. The new 265,000 square-foot freestand- ing building will be open in July 2003. It features three football- field-sized floors including 900 square-foot, open-lab research spaces, and 27 research bench- es per floor, promoting collabora- tion. Research conducted at the Cancer Institute facilities includes basic, translational and clinical research projects. It houses oncology clinics, bone- marrow transplant clinics and a pharmacy.

new 285,000-square-foot Environmental Science and Technology (ES&T) building that features a 22,000 square-foot incubator for bioscience compa- nies. Just opened January 2003, the ES&T building includes flexi- ble finished laboratory space and conference rooms, shared office space and benefits from the close proximity and synergy it shares with the Parker H. Petit Institute for Bioengineering and Biosciences (IBB) located next door on another arm. The bio- science incubator will serve both companies at Georgia Tech and those that have outgrown space at the three-year-old EmTech incubator, a commercial life sci- ences R&D center and incubator formed by Georgia Tech and Emory University in partnership with the Georgia Research Alliance and the Advanced Technology Development Center ( ATDC). EmTech houses five companies currently with 6,000 square feet of research space. One of these companies, Geovax, just announced ground- breaking news with its AIDS vaccine going to clinical trial

That's encouraging news! I've read the article, and it says that, if all goes well, the vaccine will be entering phase II later this year. I've got two questions:

1) If everything goes according to plan (and, granted, that's a big 'if'), how are the manufacturers planning to go through phases II AND III and get through all the approval paperwork to make the vaccine available to the general public within 3-4 years?

2) (The question I ask regarding all prospective therapeutic vaccines) Would it allow us to dump HAART for good?

I was worried and wondering how they would be able gear up to make millions of vaccines if they found one that works, this has had me concerned for months, but then i saw that the manufacturer of even the vaccines that the researches design is a separate vaccine manufacturer and in one case it is Pasteur, so i know and trust that french company and they have experience making millions of vaccines for many other things, so if it gets to work well, i am not worried about availability at all...

i trust the french med system, canada, and UK more than usa to do the right thing, more compassionate sensible society

I totally agree bimazek.Canada in specific is extremely up to scratch with their meds and don't really care about huge pharma' companies. This is promising news.Have you guys got a link more into the trials and results?

Phase 1 Clinical Trials of the National Institutes of Health Vaccine Research Center HIV/AIDS …HL Robinson, KJ Weinhold - The Journal of Infectious Diseases, 2006 - journals.uchicago.edu... However, HLR does have a DNA/modified vaccinia Ankara candidate vaccine in phase1 human trials that has been licensed by GeoVax, Inc., for commercial ..

this is an earlier press release when they had great results with monkeys... read this very very exciting... i feel like this is the answer i hope i need hope...

two monkeys were infected with the SIV AIDS virus and then placed on drug therapy. Thereafter, once early drug therapy had temporarily reduced virus levels, the monkeys were vaccinated with the SIV version of GeoVax's DNA/MVA vaccines. Six weeks after vaccination, drug treatment was discontinued. The SIV virus levels temporarily rose in the vaccinated individuals, but were later "controlled" ( reduced to much lower levels ) by immune responses raised by the vaccines.

The reduction of virus levels in the blood stream of these AIDS virus-infected non-human primates has continued for more than a year to date. Vaccination with the GeoVax DNA/MVA vaccines has curtailed the development of AIDS and its associated debilitating effects, resulting in healthy, asymptomatic individuals. The monkeys have gained weight and have not required any additional drug therapy.

Preclinical results of Geovax's AIDS vaccines demonstrate potential to protect against diseaseIn this trial, two monkeys were infected with the SIV AIDS virus and then placed on drug therapy. Thereafter, once early drug therapy had temporarily reduced virus levels, the monkeys were vaccinated with the SIV version of GeoVax's DNA/MVA vaccines. Six weeks after vaccination, drug treatment was discontinued. The SIV virus levels temporarily rose in the vaccinated individuals, but were later "controlled" (reduced to much lower levels) by immune responses raised by the vaccines.

In this trial, two monkeys were infected with the SIV AIDS virus and then placed on drug therapy. Thereafter, once early drug therapy had temporarily reduced virus levels, the monkeys were vaccinated with the SIV version of GeoVax's DNA/MVA vaccines. Six weeks after vaccination, drug treatment was discontinued. The SIV virus levels temporarily rose in the vaccinated individuals, but were later "controlled" ( reduced to much lower levels ) by immune responses raised by the vaccines.

The reduction of virus levels in the blood stream of these AIDS virus-infected non-human primates has continued for more than a year to date. Vaccination with the GeoVax DNA/MVA vaccines has curtailed the development of AIDS and its associated debilitating effects, resulting in healthy, asymptomatic individuals. The monkeys have gained weight and have not required any additional drug therapy.

"The results of this trial demonstrate the long-term promise of our vaccines in treating HIV-AIDS," said Don Hildebrand, CEO of GeoVax Labs. "Our preclinical trials, coupled with encouraging data from two ongoing human trials, help validate the science behind our vaccines and provide the impetus for accelerating the planning of Phase II human trials for our preventive vaccines."

The ability to vaccinate those already infected with the AIDS virus, thereby inhibiting the virus' progressive and debilitating effects, would allow individuals to fight off normal infections, live longer and maintain a more normal lifestyle. Such a vaccine, if approved for distribution, would be considerably more cost-effective and without the same side effects associated with current drug treatment programs.

The promising results from this trial have resulted in preliminary plans to conduct human therapeutic studies utilizing GeoVax's AIDS vaccines with the hope of extending the length and quality of life in people already infected with the AIDS virus.

ATLANTA, Feb. 5 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc. an Atlanta-based biotechnology company, today reported successful early results from two ongoing AIDS prevention Phase I human vaccine trials. Results from the first low dose trial indicate a good safety profile as well as positive immune responses in human volunteers receiving 1/10th dose of GeoVax's AIDS vaccine. Results from a second larger full dose trial also indicate a good safety profile in participants. The GeoVax vaccines being tested are designed to prevent the development of Acquired Immunodeficiency Disease ("AIDS") caused by the virus known as HIV-1 by vaccinating individuals prior to infection with the AIDS virus.

* Demonstrate a very acceptable safety profile in an ongoing 1/10th dose trial begun in April, 2006 * Indicate that as low as 1/10th of a full dose of GeoVax's HIV/AIDS vaccine stimulates potentially protective anti-HIV-1 immune responses in the majority of vaccine recipients * Suggest an acceptable safety profile in an ongoing full dose trial begun Sept 2006 * Suggest that a full dose of the vaccine will stimulate an even better immune response in recipients participating in the full dose trial; data is expected later in 2007 * Support accelerated planning for a large Phase II human trial including more than 300 participants across North and South America and the Caribbean and with an earlier start date than originally anticipated

The 1/10th dose trial, begun April, 2006, is evaluating GeoVax's AIDS vaccines primarily for their safety and potential efficacy as a preventative vaccine administered to people prior to infection with the HIV-1 virus, thus preventing the development of AIDS. A positive human immune response to the vaccine is indicated by the presence of antibodies and T cells (white blood cells) that recognize and control viral infections.

"We are very encouraged by the positive immune responses in six human volunteers receiving only 1/10th of a dose of vaccine," said Dr. Harriet Robinson, GeoVax's Chief Scientific Advisor and developer of the AIDS vaccine. "This trial group consisted of 11 volunteers, with two individuals that received no vaccine as part of the blinded study. In this group, only 1/10th of a dose of GeoVax's DNA vaccine was administered at week 0 and at week 8 to prime the immune response. The immune response was then boosted by administration of 1/10th of a dose of GeoVax's MVA vaccine at week 16 and again at week 24."

The vaccine response was determined in tests conducted on human blood samples collected after vaccination. These assays were conducted at the Emory University Vaccine Center under the guidance of Dr. Harriet Robinson.

Based on the excellent safety demonstrated in the 1/10th dose vaccine trial, a full dose human trial started in September, 2006. Thus far, the trial has enrolled 36 volunteers. Thirty of the volunteers received the vaccine, while six control subjects received a placebo (no vaccine). The full dose of AIDS vaccine approximates the dose size that protected 22 of 23 (96%) of non- human primates for more than 3 1/2 years against development of AIDS. The immune response generated in the majority of volunteers receiving 1/10th dose of GeoVax's vaccines suggests that the vaccines, when administered at full dose, may elicit outstanding responses.

More information will be released on the full dose trial when available later in 2007. GeoVax's AIDS vaccines contain only part of the HIV-1 virus and cannot cause AIDS. These vaccines contain the three major genes of the HIV- 1/AIDS virus and mimic actual virus infections by producing non-infectious HIV-like particles in vaccinated individuals.

The human trials, utilizing GeoVax's AIDS vaccines, are being conducted by the HIV Vaccine Trials Network (HVTN), based in Seattle, Washington. The HVTN, which is funded and supported by the National Institutes of Health, is the largest worldwide clinical trials program devoted to the development and testing of HIV/AIDS vaccines. Preclinical work enabling development of the clinical evaluation of GeoVax's DNA and MVA vaccines was also funded and supported by the National Institutes of Health and the National Institute of Allergy and Infectious Diseases.

Safe Harbor Statement

All statements in this news release that are not statements of historical fact are forward-looking statements. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, whether; GeoVax can develop these vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be determined to be safe for use in humans, GeoVax's vaccines will be effective in preventing AIDS in humans, the vaccines will receive the regulatory approvals necessary to be licensed and marketed, GeoVax can raise the required capital to complete development of its vaccines, there is development of competitive products that may be more effective or easier to use than GeoVax's products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. Certain matters discussed in this news release are forward looking statements involving certain risks and uncertainties including, without limitations, risks detailed in the Companies Securities and Exchange Commission filings and reports.

I've never posted here before, but this looks like it has so much breakthrough potential I thought I'd say something ... we've heard so much hype in the past but Emory is doing the research on this and its credibility is up there with Harvard and Princeton so if they're saying we can have a potent vaccine in 3-4 years they're not the kind of people to exaggerate ... at the same time I'm not doing backflips yet ... but I might in 3-4 years

Background: Many researchers agree that a successful HIV vaccine will include a component to elicit broadly neutralizing antibodies. However, the target of such antibodies, the envelope spike, has evolved many features to evade antibody neutralization; therefore, classical approaches to vaccine design based on simple mimicry of natural infection are unsuccessful. More promising are rational vaccine design approaches focused on understanding spike structure and the interaction of spikes with broadly neutralizing antibodies. These approaches face major challenges, particularly in translating predictable antigen behavior to predictable immunogen behavior. In addition, there are still major uncertainties about the levels of neutralizing antibody that will provide benefit against human exposure to HIV.

Conclusions: The progress to date and challenges to be faced in developing an antibody-eliciting component of an HIV vaccine will be critically surveyed.

The 1/10th dose trial, begun April, 2006, is evaluating GeoVax's AIDS vaccines primarily for their safety and potential efficacy as a PREVENTIVE vaccine administered to people prior to infection with the HIV-1 virus, thus preventing the development of AIDS. A positive human immune response to the vaccine is indicated by the presence of antibodies and T cells (white blood cells) that recognize and control viral infections.

Source: GeoVax Labs, Inc.

This is a PREVENTIVE one, not THERAPEUTIC one. Does it means it will NOT working on us, only work for those people who is not infected? I feel soooo low.........

Yes, this one is a vaccine that injects part of the HIV-1 virus in the body to prepare the immune system against the real HIV. A therapeutic vaccine is one that activates stronger immunity AFTER the infection.

This is a PREVENTIVE one, not THERAPEUTIC one. Does it means it will NOT working on us, only work for those people who is not infected? I feel soooo low.........

Actually, according to the info Bimazek posted, both approaches are being or will apparently be studied:

"The ability to vaccinate those already infected with the AIDS virus, thereby inhibiting the virus' progressive and debilitating effects, would allow individuals to fight off normal infections, live longer and maintain a more normal lifestyle. Such a vaccine, if approved for distribution, would be considerably more cost-effective and without the same side effects associated with current drug treatment programs.

The promising results from this trial have resulted in preliminary plans to conduct human therapeutic studies utilizing GeoVax's AIDS vaccines with the hope of extending the length and quality of life in people already infected with the AIDS virus."